Sphincterotome
K号: K260962 · 2026-05-21
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决定日期2026-05-21
产品代码KNS
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K260962. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sphincterotome?
Sphincterotome is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K260962.
When did Sphincterotome receive FDA 510(k) clearance?
Sphincterotome received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260962.
Who is the listed applicant for Sphincterotome?
The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sphincterotome?
The FDA product code for Sphincterotome is KNS.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Taewoong Medical Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KNS）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262460Rezum系统Boston ScientificK252388征服水蒸气消融装置Francis Medical, Inc.K252889一次性3腔针刀V（KD-V441M，KD-V451M）Olympus Medical Systems CorporationK250945一次性预装括约肌刀V（远端导丝引导）（KD-VC600系列）；一次性括约肌刀V（远端导丝引导）（KD-VC400系列）；一次性三腔括约肌刀（KD-V系列）；一次性三腔括约肌刀（KD系列）Olympus Medical Systems Corp.K250351一次性电外科刀 (KD-612L, KD-612U)；一次性电外科刀 (KD-620UR)；一次性电外科刀 (KD-650L, KD-650U)Olympus Medical Systems CorporationK251104SureTome® SW 球囊切开器带圆顶尖Wilson-Cook Medical
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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